V.A.C.Via

Main information

  • Trade name:
  • V.A.C.Via Negative Pressure Wound Therapy System - Negative-pressure wound therapy system, battery-powered, single-use
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • V.A.C.Via Negative Pressure Wound Therapy System - Negative-pressure wound therapy system, battery-powered, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216529
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216529

KCI Medical Australia Pty Ltd - V.A.C.Via Negative Pressure Wound Therapy System - Negative-pressure

wound therapy system, battery-powered, single-use

ARTG entry for

Medical Device Included Class IIb

Sponsor

KCI Medical Australia Pty Ltd

Postal Address

PO Box 1541,LANE COVE, NSW, 1595

Australia

ARTG Start Date

24/10/2013

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

KCI USA Inc

12930 IH 10 West

San Antonio, TX, 78249

United States Of America

Products

1. V.A.C.Via Negative Pressure Wound Therapy System - Negative-pressure wound therapy system,

battery-powered, single-use

Product Type

Medical device system

Effective date

24/10/2013

GMDN

58202 Negative-pressure wound therapy system, battery-powered, single-use

Intended purpose

The V.A.C. ® Via™ Therapy System is an integrated wound management system for use in acute,

extended and home care settings. When used on open wounds, it is intended to create an environment

that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound

bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing

exudates and infectious material. Open wound types include: chronic, acute, traumatic, subacute and

dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency),

flaps and grafts.

When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that

continue to drain following sutured or stapled closure by maintaining a closed environment and removing

exudates via the application of negative pressure wound therapy.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 23.11.2017 at 04:06:48 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information